Computing Networks and Systems for Submitting Data

ABSTRACT

Systems and methods are provided for submitting data in a computer network. An exemplary method includes: receiving a first request to process a first data at one or more data servers; determining whether the first data includes a plurality of first set of properties; generating a second data having a plurality of second set of properties; providing a plurality of rule sets for submitting the second data; analyzing the second data to determine which of the rule sets is applicable; selecting one or more applicable rules from the rule sets; generating a plurality of third data by applying the one or more applicable rules to the second data; identifying the one or more external sources to distribute the third data; and sending the third data to the one or more external sources.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to and is a continuation of U.S. patentapplication Ser. No. 17/230,752, filed Apr. 14, 2021, the disclosure ofwhich is incorporated by reference in its entirety for all purposes.

TECHNICAL FIELD

The present disclosure relates to methods and systems for accessing,sharing, and submitting data using complex computing networks.

BACKGROUND

Researchers, scientists, industry players, academics, governmentregulators, and other stakeholders are increasingly in need ofsubmitting data across a vast area of computer networks.

SUMMARY

According to one aspect of the subject matter described in thisdisclosure, method for submitting data in a computer network isprovided. The method includes the following: receiving, using one ormore computing device processors, a first request to process a firstdata at one or more data servers; determining, using the one or morecomputing device processors, whether the first data includes a pluralityof first set of properties; generating, using the one or more computingdevice processors and the first set of properties, a second data havinga plurality of second set of properties; storing, using the one or morecomputing device processors, the second data at the one or more dataservers; providing, using the one or more computing device processors,at least one rule set for submitting second data to one or more externalsources, wherein each of the at least one rule set comprises one or morerule parameters for submitting the second data; analyzing, using the oneor more computing device processors, the second data to determine whichone or more rules from the at least one rule set is applicable forsubmitting the second data to the one or more external sources;selecting, using the one or more computing device processors, one ormore applicable rules from the at least one rule set based on theanalysis of the second data; storing, using the one or more computingdevice processors, the one or more applicable rules in the one or moredata servers; retrieving, using the one or more computing deviceprocessors, the second data from the one or more data servers;determining, using the one or more computing device processors, whetherthe second data includes update information for updating the seconddata; in response to the user entering update information for the seconddata, receiving, using the one or more computing device processors, theupdate information; in response to receiving the update information,updating, using the one or more computing device processors, the seconddata to include the update information; retrieving, using the one ormore computing device processors, the one or more applicable rules fromthe one or more data servers; generating, using the one or morecomputing device processors, a plurality of third data by applying theone or more applicable rules to the second data, wherein the third datacomprises a plurality of third set of properties; formatting, using theone or more computing device processors, the third data in accordancewith the one or more applicable rules; initiating, using the one or morecomputing device processors, display of the third data and the third setof properties; identifying, using the one or more computing deviceprocessors and the third set of properties, the one or more externalsources to distribute the third data; and sending, using the one or morecomputing device processors, the third data to the one or more externalsources based on at least one of the third set of properties.

According to another aspect of the subject matter described in thisdisclosure, a system for submitting data in a computer network isprovided. The system includes one or more computing device processors.One or more computing device memories are coupled to the one or morecomputing device processors. The one or more computing device memoriesstore instructions executed by the one or more computing deviceprocessors, the instructions are configured to: receive a first requestto process a first data at one or more data servers, wherein the one ormore data servers store the first data; determine whether the first dataincludes a plurality of first set of properties; generate, using thefirst set of properties, a second data having a plurality of second setof properties; store the second data at the one or more data servers;provide a plurality of rule sets for submitting second data to one ormore external sources, wherein each of the rule sets comprises one ormore rule parameters for submitting the second data; analyze the seconddata to determine which of the rule sets is applicable for submittingthe second data to the one or more external sources; select one or moreapplicable rules from the rule sets based on the analysis of the seconddata; store the one or more applicable rules in the one or more dataservers; retrieve the second data from the one or more data servers;determine whether the second data includes the update information forupdating the second data; in response to the user entering the updateinformation for the second data, receive the update information; inresponse to receiving the update information, update the second data toinclude the update information; retrieve the one or more applicablerules from the one or more data cloud servers; generate a plurality ofthird data by applying the one or more applicable rules to the seconddata, wherein the third data comprises a plurality of third set ofproperties; format the third data in accordance with the one or moreapplicable rules; initiate display of the third data and the third setof properties; identify, using the third set of properties, the one ormore external sources to distribute the third data; and send the thirddata to the one or more external sources.

According to another aspect of the subject matter described in thisdisclosure, a method for submitting data in a computer network isprovided. The method includes the following: receiving, using one ormore computing device processors, a first request to process a firstdata at one or more data cloud servers, wherein the one or more datacloud servers store the first data; determining, using the one or morecomputing device processors, whether the first data includes at leastone of a plurality of first set of properties; generating, using the oneor more computing device processors and the at least one of the firstset of properties, a second data having at least one of a plurality ofsecond set of properties; storing, using the one or more computingdevice processors, the second data at the one or more data cloudservers; providing, using the one or more computing device processors, aplurality of rule sets for submitting second data to one or moreexternal sources, wherein each of the rule sets comprises one or morerule parameters for submitting the second data; analyzing, using the oneor more computing device processors, the second data to determine whichrule from the at least one rule set is applicable for submitting thesecond data to the one or more external sources; selecting, using theone or more computing device processors, one or more applicable rulesfrom the rule sets based on the analysis of the second data; storing,using the one or more computing device processors, the one or moreapplicable rules in the one or more data cloud servers; retrieving,using the one or more computing device processors, the second data fromthe one or more data cloud servers; determining, using the one or morecomputing device processors, whether the second data includes updateinformation for updating the second data; in response to the userentering the update information for the second data, receiving, usingthe one or more computing device processors, the update information; inresponse to receiving the update information, updating, using the one ormore computing device processors, the second data to include the updateinformation; retrieving, using the one or more computing deviceprocessors, the one or more applicable rules from the one or more datacloud servers; generating, using the one or more computing deviceprocessors, a plurality of third data by applying the one or moreapplicable rules to the second data, wherein the third data comprises aplurality of third set of properties; formatting, using the one or morecomputing device processors, the third data in accordance with the oneor more applicable rules; initiating, using the one or more computingdevice processors, display of the third data and the third set ofproperties; identifying, using the one or more computing deviceprocessors and the third set of properties, the one or more externalsources to distribute the third data; and sending, using the one or morecomputing device processors, the third data to the one or more externalsources.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosure is illustrated by way of example, and not by way oflimitation in the figures of the accompanying drawings in which likereference numerals are used to refer to similar elements. The variouselements shown in the figures that follow may be optional depending on agiven embodiment without departing from the principles provided in thisdisclosure.

FIG. 1 is a high-level network system for accessing, managing, andsharing structured data, according to one embodiment.

FIG. 2A is a functional block diagram of a computing environment foraccessing and visualizing structured data, according to one embodiment.

FIG. 2B is a detailed system diagram of FIG. 2A, according to oneembodiment.

FIG. 3 shows an example interface listing of rule sets stored in a datacloud server, according to one embodiment.

FIG. 4 shows an example interface listing all rule parameters used todefine a rule, according to one embodiment.

FIG. 5 shows an example interface illustrating a detailed view ofadverse event reports received by a data cloud server, according to oneembodiment.

FIG. 6 shows an example interface illustrating a detailed view of acase, according to one embodiment.

FIG. 7 shows an example interface for editing and reviewing informationof a submitted case, according to one embodiment.

FIG. 8 shows an example interface illustrating what occurs whensubmission information has been re-evaluated, according to oneembodiment.

FIG. 9 shows a table listing illustrating several rules of a rule set,according to one embodiment.

FIG. 10 shows the applicability of the rules in premarket and postmarketstudies, according to one embodiment.

FIG. 11 shows a table listing illustrating the rules of a rule set shownin FIG. 10, according to one embodiment.

FIG. 12 shows an example interface illustrating a detailed view oftransmission profiles used to prepare submissions, according to oneembodiment.

FIG. 13 shows an example interface illustrating a detailed view ofproduct information, according to one embodiment.

FIG. 14 shows an example interface illustrating a detailed view of druginformation used to prepare submissions, according to one embodiment.

FIG. 15 shows an example interface illustrating the case where backreporting is not performed, according to one embodiment.

FIG. 16 shows an example interface illustrating the case where backreporting is performed, according to one embodiment.

FIGS. 17A-17B show flowcharts illustrating method for submitting data ina computer network, according to one embodiment.

DETAILED DESCRIPTION

The figures and descriptions provided herein may have been simplified toillustrate aspects that are relevant for a clear understanding of theherein described devices, systems, and methods, while eliminating, forthe purpose of clarity, other aspects that may be found in typicalsimilar devices, systems, and methods. Those of ordinary skill mayrecognize that other elements and/or operations may be desirable and/ornecessary to implement the devices, systems, and methods describedherein. But because such elements and operations are well known in theart, and because they do not facilitate a better understanding of thepresent disclosure, a discussion of such elements and operations may notbe provided herein. However, the present disclosure is deemed toinherently include all such elements, variations, and modifications tothe described aspects that would be known to those of ordinary skill inthe art.

The terminology used herein is for the purpose of describing particularexample embodiments only and is not intended to be limiting. Forexample, as used herein, the singular forms “a”, “an” and “the” may beintended to include the plural forms as well, unless the context clearlyindicates otherwise. The terms “comprises,” “comprising,” “including,”and “having,” are inclusive and therefore specify the presence of statedfeatures, integers, steps, operations, elements, and/or components, butdo not preclude the presence or addition of one or more other features,integers, steps, operations, elements, components, and/or groupsthereof. The method steps, processes, and operations described hereinare not to be construed as necessarily requiring their performance inthe particular order discussed or illustrated, unless specificallyidentified as an order of performance. It is also to be understood thatadditional or alternative steps may be employed.

Although the terms first, second, third, etc., may be used herein todescribe various elements, components, regions, layers and/or sections,these elements, components, regions, layers and/or sections should notbe limited by these terms. These terms may be only used to distinguishone element, component, region, layer or section from another element,component, region, layer or section. That is, terms such as “first,”“second,” and other numerical terms, when used herein, do not imply asequence or order unless clearly indicated by the context.

System Environment

Illustrated in FIG. 1 is a high level network system 100 for generatinginterfaces that access, maintain, analyze, and display structured data.In the depicted implementation, the system 100 may include a data cloudserver 105 communicatively coupled to a plurality of secure computingenvironments 125 external sources 112 via the network 110. The securecomputing environments 125 may in turn be communicatively coupled to alocal repository 130. While a single data cloud server 105 isillustrated, the disclosed principles and techniques could be expandedto include multiple data cloud servers 105.

The data cloud server 105, according to some embodiments, is configuredto store a plurality of structured data in a secure environmentrequiring authentication before access is granted to the structureddata. According to one implementation, the structured data includeshierarchical data having varying and connected categories/levels thatdescribe a plurality of aspects of the structured data. In some cases,the structured data in the data cloud server 105 is sourced or obtainedfrom third-party scientific sources, and/or from third-party regulatoryagencies, and/or from academic sources, and/or from industrial sources,etc.

In addition, the data cloud server 105 may be configured to manage orotherwise maintain the integrity and/or version updates of thestructured data so that a user (e.g., a user of the secure computingenvironment) does not have to deal with such data maintenance processesas the structured data changes and/or grows. In one embodiment, the datacloud server 105 provides the most current version of the structureddata to a user of the system. In other embodiments, the data cloudserver 105 can also provide historical versions of the structured datawhen necessary or needed. Furthermore, the data cloud server 105 mayinclude mechanisms that execute operations of data decompressionoperations, data decryption operations, and data decoding operationsassociated with the structured data so that the user is effectivelyisolated from such operations.

Moreover, the data cloud server 105 allows for easy associating,tagging, or coding of information for retrieval purposes. In some cases,the tagging or coding is automatically executed by the data cloud server105. In addition, the data cloud server 105 allows a user (e.g., user ofthe secure computing environment 125) to transition from accessingstructured data from the local repository 130 to the data cloud server105.

The data cloud server 105 may be implemented within a computing devicesuch as a mainframe server, a content server, a communication server, alaptop computer, a desktop computer, a handheld computing device, avirtual machine, a cloud-based computing solution and/or service, and/orthe like. The data cloud server 105 may include a plurality of computingdevices configured to communicate with one another and/or implement thetechniques described herein. In some instances, the data cloud server105 may include various elements of a computing environment as describedwith reference to FIGS. 2A and/or 2B. For example, the data cloud server105 may include a processing system 202, a memory 204, an input/output(I/O) system 206, and a communication system 208. A user (e.g., databaseadministrator) may operate/maintain the data cloud server 105 eitherlocally or remotely as the case may require.

The data cloud server 105 may be configured to have storage logic thatis executable to store structured data that is shared across multiplesecure computing environments 125. According to one implementation, thedata cloud server 105 may include a plurality ofnon-volatile/non-transitory storage media such as solid state storagemedia, hard disk storage media, virtual storage media, cloud-basedstorage drives, storage servers, and/or the like. The plurality ofstorage media may be configured to store data from a plurality ofsources. For example, the data cloud server 105 may include storagelogic that is executable to store structured data derived from, forexample, medical data, research data, education data, government data,etc. According to some implementations, the storage logic of the datacloud server 105 may be configured to automatically monitor and/orupdate relevant structured data obtained from a third-party source. Forexample, the storage logic of the data cloud server 105 may periodicallymonitor updates associated with structured data (e.g., dictionary ofmedical terms for research and regulatory purposes) from third-partyorganizations/sources and automatically update different versions of thestructured data within one or more storage media of the data cloudserver 105. In one embodiment, the storage logic of the data cloudserver 105 manipulates or otherwise formats the structured data suchthat user interfaces generated by a secure computing environment 125 canseamlessly access/retrieve and present the structured data to a user. Inaddition, structured data from the data cloud server 105 may be accessedon a regulated basis via credential access, for example. This regulatedbasis may be determined, in part, by licenses, privileges, and otherlevels of authorization dictated by a user's credentials.

The external source 112 may operate similarly like the data cloud server105 including having all the technical features of the data cloud server105 described herein. The difference between the external source 112 andthe data cloud server 105 is the external source 112 operates inproviding information to the data cloud server 105 when requested. Whilea single external source 112 is illustrated, the disclosed principlesand techniques could be expanded to include multiple external sources112.

The local repository 130 may include storage logic for storing a localcopy of structured data from the data cloud server 105. The localrepository 130 may also be configured to store data other than thestructured data. For example, the local repository 130 may store datafrom third-party sources and other data generated by the securecomputing environment 125. The local repository may include a pluralityof non-volatile/non-transitory storage media such as solid state storagemedia, hard disk storage media, virtual storage media, cloud-basedstorage drives, storage servers, and/or the like. According to someembodiments, the local repository 130 may include logic that updatesstructured data stored within its storage devices based on updates tostructured data stored within the data cloud server 105. In some cases,snapshots of structured data may be accessed using the secure computingenvironment 125 so that updates associated with the snapshots may beeffected on the local repository 130.

As previously discussed, the network 110 facilitates communicationbetween the data cloud server 105, the external source 112, and thesecure computing environment 125. The network 110 may also allowdifferent secure computing environments 125 to communicate with eachother. According to one embodiment, the network 110 may include aplurality of networks. For instance, the network 110 may include anywired/wireless communication network that facilitates communicationbetween the components of the network system 100. The network 110, insome instances, may include an Ethernet network, a cellular network, acomputer network, the Internet, a wireless fidelity (Wi-Fi) network, alight fidelity (Li-Fi) network, a Bluetooth network, a radio frequencyidentification (RFID) network, a near-field communication (NFC) network,a fiber optics network, a laser-based network, and/or the like.

The secure computing environment 125 is configured to generate one ormore user interfaces for accessing, analyzing, and displaying thestructured data. According to some implementations, the secure computingenvironment 125 includes functionalities and/or enhanced securityfeatures that allow a user to securely access and/or securely managestructured data. As shown more clearly in the exemplary functional andsystem diagrams of FIGS. 2A and 2B, the secure computing environment 125includes a processing system 202, a memory 204, and I/O system 206, anda communication system 208. The processing system 202, the memory 204,the I/O system 206, and the communication system 208 may include one ormore subsystems that perform one or more of the operations describedherein. Additionally, each system of the secure computing environment125 may be operatively and/or otherwise communicatively coupled witheach other so as to facilitate one or more operations described herein.The secure computing environment 125 may include general hardware,specifically-purposed hardware, and/or a combination thereof.

The processing system 202 may control the memory 204, the I/O system206, and the communication system 208, as well as any includedsubsystems, elements, components, devices, and/or functions performed bythe memory 204, I/O system 206, and the communication system 208.Additionally, any actions described in this disclosure as beingperformed by a processor or one or more processors of a computing deviceor one or more computing device processors and/or one or more computingsystem processors may be executed by the processing system 202 of FIGS.2A and 2B. Further, while one processing system 202 is shown in FIGS. 2Aand 2B, multiple processing systems may be present and/or otherwiseincluded in the secure computing environment 125 or elsewhere in theoverall network system 100 of FIG. 1. Thus, while instructions may bedescribed as being executed by the processing system 202 (and/or varioussubsystems of the processing system 202), the instructions may beexecuted simultaneously, serially, and/or otherwise by one or multipleprocessing systems 202 on one or more computing devices.

According to one embodiment, the processing system 202 may beimplemented as one or more computer processor chips and/or graphicalprocessing unit (GPU) chips and may include a hardware device capable ofexecuting computer instructions. The processing system 202 may executeinstructions, codes, computer programs, and/or scripts. Theinstructions, codes, computer programs, and/or scripts may be receivedfrom the I/O system 206, the communication system 208, and/or stored inthe memory 204, and/or received from the other subsystems of the securecomputing environment 125 and/or received from other computingenvironments.

In some embodiments, the processing system 202 may include subsystemssuch as a content management subsystem 212, a graphical processingsubsystem 216, and a resource allocation subsystem 218. Each of theaforementioned subsystems of the processing system 202 may becommunicatively or operably coupled to each other.

The content management sub-system 212 may facilitate generation,modification, analysis, transmission, and/or presentation of content.Content may be file content, media content, structured data content,user interfaces, or any combination thereof. In some instances, contenton which the content management system 212 operates includes structureddata from the data cloud server 105, structured data from the localrepository 130, user interface data, device information, images, text,themes, audio files, video files, documents, and/or the like.Additionally, the content management subsystem 212 may control theaudio-visual environment and/or appearance of application data duringexecution of various processes. In some embodiments, the contentmanagement subsystem 212 may interface with a third-party content serverand/or third-party memory locations for execution of its operations.

The graphical processing subsystem 216 may facilitate generation,modification, analysis, processing, transmission, and/or presentation ofthe content described above, as well as any data described herein. Insome embodiments, the graphical processing subsystem 216 may be used torender content for presentation on a computing device (e.g., via agraphical user interface of the computing device). The graphicalprocessing subsystem 216 may also include multiple graphical processingsubsystems and therefore may be configured to perform and/or executemultiple processes in parallel. In some implementations, the graphicalprocessing subsystem 216 may be used in conjunction with components ofthe memory 204, the I/O system 206, the communication system 208, and/ora combination thereof.

The resource allocation subsystem 218 may facilitate the determination,monitoring, analysis, and/or allocation of computing resourcesthroughout the secure computing environment 125 and/or other computingenvironments. Computing resources of the secure computing environment125 may be used by the processing system 202, the memory 204, the I/Osystem 206, and/or the communication system 208. These resources mayinclude processing power, data storage space, network bandwidth, and/orthe like. Accordingly, the resource allocation subsystem 218 may includesensors and/or other specially-purposed hardware for monitoringperformance of each system and/or subsystem of the secure computingenvironment 125, as well as hardware for responding to thecomputing-resource needs of each system and/or subsystem. In someembodiments, the resource allocation subsystem 218 may use computingresources of a second secure computing environment separate and distinctfrom the secure computing environment 125 to facilitate a desiredoperation.

The memory 204 may be used for storing, recalling, receiving,transmitting, and/or accessing various files and/or data (e.g.,structured data) during the operation of the secure computingenvironment 125. For example, the memory 204 may store, recall, and/orupdate structured data from the data cloud and/or the local repositoryas the case may be. In some embodiments, the memory 204 may storeinstructions and/or data that may be executed by the processing system202. For instance, the memory 204 may store instructions that executeoperations associated with one or more systems and/or one or moresubsystems of the secure computing environment 125. For example, thememory 204 may store instructions for the processing system 202, the I/Osystem 206, the communication system 208, and for itself.

Memory 204 may include various types of data storage media such as solidstate storage media, hard disk storage media, virtual storage media,and/or the like. Memory 204 may include dedicated hardware elements suchas hard drives and/or servers, as well as software elements such ascloud-based storage drives. In some implementations, memory 204 may be arandom access memory (RAM) device, a dynamic random access memory (DRAM)device, a static random access memory (SRAM) device, flash memory, readonly memory (ROM) device, and/or various forms of secondary storage. TheRAM device may be used to store volatile data and/or to storeinstructions that may be executed by the processing system 202. Forexample, the instructions stored may be a command, a current operatingstate of secure computing environment 125, an intended operating stateof secure computing environment 125, and/or the like. As a furtherexample, data stored in the memory 204 may include instructions relatedto various methods and/or functionalities described herein. The ROMdevice may be a non-volatile memory device that may have a smallermemory capacity than the memory capacity of a secondary storage of thesecure computing environment. The ROM device may be used to storeinstructions and/or data that may be read during execution of computerinstructions. In some embodiments, access to both the RAM device and ROMdevice may be faster to access than access to the secondary storage ofthe secure computing environment 125. Secondary storage may comprise oneor more disk drives and/or tape drives which may be used fornon-volatile/non-transitory storage of data or as an over-flow datastorage device of the secure computing environment 125 if the RAM deviceis not large enough to hold all working data. Secondary storage may beused to store programs that may be loaded into the RAM device when suchprograms are selected for execution.

Turning back to FIG. 2A, the memory 204 may include subsystems such asapplication data 228, application programming interface 230, contentstorage 232, and cache storage 240. Application data 228 may facilitatedeployment, storage, access, execution, and/or utilization of anapplication utilized by the secure computing environment 125 and/or anyother computing environments described herein. As such, application data228 may store any information and/or data associated with anapplication. Application data 228 may further store various pieces ofinformation and/or data associated with the operation of an applicationand/or with the secure computing environment 125 as a whole, such as astatus of computing resources (e.g., processing power, memoryavailability, resource utilization, and/or the like), runtimeinformation, user interfaces, systems to direct execution of operationsdescribed herein to, user permissions, security credentials, and/or thelike.

The application programming interface (API) 230 may facilitatedeployment, storage, access, execution, and/or utilization ofinformation associated with APIs of secure computing environment 125and/or any other computing environment described herein. For example,secure computing environment 125 may include one or more APIs forvarious devices, applications, systems, subsystems, elements, and/orother computing environments to allow communication between one or moreapplications associated with the secure computing environment 125.Accordingly, API 230 may include API databases containing informationthat may be accessed and/or used by applications, systems, subsystems,elements, and/or operating systems of other devices and/or computingenvironments in communication with the secure computing environment 125.In some cases, the API 230 may enable the data cloud server 105 and thesecure computing environment 125 to communicate with each other.

The content storage 232 may facilitate deployment, storage, access,and/or utilization of information associated with structured data asfurther discussed below. In one embodiment, content storage 232 maycommunicate with a content management system 212 to receive and/ortransmit content (e.g., structured data, media content, etc.).

The I/O system 206 may include hardware and/or software elements for thesecure computing environment 125 to receive, and/or transmit, and/orpresent information useful for generating one or more interfaces forretrieving and displaying structured data according to some embodimentsof this disclosure. For example, elements of the I/O system 206 may beused to receive input from a user of the secure computing environment125. As described herein, I/O system 206 may include subsystems such asI/O device 242, I/O calibration subsystem 244, and/or driver 246.

The I/O device 242 may facilitate the receipt, transmission, processing,presentation, display, input, and/or output of information as a resultof executed processes described herein. In some embodiments, the I/Odevice 242 may include a plurality of I/O devices. In some embodiments,I/O device 242 may include a variety of elements that enable a user tointerface with secure computing environment 125. For example, I/O device242 may include a keyboard, a touchscreen, a button, a sensor, abiometric scanner, a laser, a microphone, a camera, and/or anotherelement for receiving and/or collecting input from a user. Additionallyand/or alternatively, I/O device 242 may include a display, a screen, asensor, a vibration mechanism, a light emitting diode (LED), a speaker,a radio frequency identification (RFID) scanner, and/or another elementfor presenting and/or otherwise outputting data to a user. In someembodiments, the I/O device 242 may communicate with one or moreelements of processing system 202 and/or memory 204 to executeoperations associated with generating user interfaces for retrieving andvisualizing structured data.

The I/O calibration system 244 may facilitate the calibration of the I/Odevice 242. For example, I/O calibration system 244 may detect and/ordetermine one or more settings of I/O device 242, and then adjust and/ormodify settings so that the I/O device 242 may operate more efficiently.In some embodiments, I/O calibration system 244 may use a driver 246 (ormultiple drivers) to calibrate I/O device 242 as needed. For example,driver 246 may include software that is to be installed by I/Ocalibration system 244 so that an element of secure computingenvironment 125 (or an element of another computing environment) mayrecognize and/or integrate with I/O device 242.

The communication system 208 may facilitate establishment, maintenance,monitoring, and/or termination of communications between the securecomputing environment 125 and other computing environments, third-partyserver systems, and/or the like. Communication system 208 may alsofacilitate internal communications between various elements (e.g.,systems and/or subsystems) of secure computing environment 125. In someembodiments, communication system 208 may include a network protocolsubsystem 248, an API gateway 250, an encryption engine 252, and/or acommunication device 254. These systems and/or subsystems of thecommunication system 208 may be implemented as hardware, software, or acombination thereof.

The network protocol subsystem 248 may facilitate establishment,maintenance, and/or termination of a communication connection for thesecure computing environment 125 via a network (e.g., network 110). Forexample, network protocol subsystem 248 may detect and/or define acommunication protocol required by a particular network and/or networktype. Communication protocols utilized by network protocol subsystem 248may include Wi-Fi protocols, Li-Fi protocols, cellular data networkprotocols, Bluetooth® protocols, internet protocols, WiMAX protocols,Ethernet protocols, power line communication (PLC) protocols, and/or thelike. In some embodiments, facilitation of communication for the securecomputing environment 125 may include transforming and/or translatingdata from a first communication protocol to a second communicationprotocol. In some embodiments, network protocol subsystem 248 maydetermine and/or monitor an amount of data traffic to determine whichnetwork protocol is to be used for establishing a secure communicationconnection, transmitting data, and/or performing retrieval andsubsequent visualization of structured data.

The application programming interface (API) gateway 250 may allow otherdevices and/or computing environments and/or applications external tothe secure computing environment 125 to access the API 230 of the memory204. For example, a computing system may access the API 230 of thesecure computing environment 125 via the API gateway 250. In someembodiments, API gateway 250 may be required to validate usercredentials associated with a user of a computing device (e.g., a deviceexternal to the secure computing environment 125) prior to providingaccess to the API 230 to the user. API gateway 250 may includeinstructions for the secure computing environment 125 and therebycommunicate with external devices and/or between components of thesecure computing environment 125.

The encryption engine 252 may facilitate translation, encryption,encoding, decryption, and/or decoding of information received,transmitted, and/or stored by the secure computing environment 125.Using encryption engine 252, each transmission of data may be encrypted,encoded, and/or translated for security reasons, and any received datamay be encrypted, encoded, and/or translated prior to its processingand/or storage. In some embodiments, encryption engine 252 may generatean encryption key, an encoding key, a translation key, and/or the like,which may be transmitted along with any data content.

The communication device 254 may include a variety of hardware and/orsoftware specifically purposed to facilitate communication for securecomputing environment 125 with external systems and/or devices. In someembodiments, communication device 254 may include one or more radiotransceivers, chips, analog front end (AFE) units, antennas, processingunits, memory, other logic, and/or other components to implementcommunication protocols (wired or wireless) and related functionalityfor facilitating communication for system 125. Additionally and/oralternatively, communication device 254 may include a modem, a modembank, an Ethernet device such as a router or switch, a universal serialbus (USB) interface device, a serial interface, a token ring device, afiber distributed data interface (FDDI) device, a wireless local areanetwork (WLAN) device and/or device component, a radio transceiverdevice such as code division multiple access (CDMA) device, a globalsystem for mobile communications (GSM) radio transceiver device, auniversal mobile telecommunications system (UMTS) radio transceiverdevice, a long term evolution (LTE) radio transceiver device, aworldwide interoperability for microwave access (WiMAX) device, and/oranother device used for communication purposes.

User Interfaces

In performing the operations shown in FIGS. 3-16, the example interfacesdescribed herein may communicate with data cloud server 105 to accessinformation either from the data cloud server 105 or the external source112. The example interfaces described herein may be implemented on thesecure computing environment 125 or alternatively on even a separateserver/computer system coupled to network 110. Moreover, the exampleuser interfaces described herein may utilize the communication resourcesof the secure computing environment 125 described herein to communicatewith data cloud server 105. In addition, example user interfacesdescribed in FIGS. 3-16 may utilize the communication resources of theseparate server/computer system to communicate with data cloud server105.

External source 112 may send a number of adverse event reports (AERs) todata cloud server 105 via network 110. The data cloud server 105 may usethe AERs to devise new cases. The data cloud server 105 may evaluatewhich of the cases may require submissions and distribution to thedifferent secure compute environments 125. In particular, the data cloudserver 105 may include a number of rule sets defining the format of asubmission as well as which of the secure compute environments 125 mayreceive the submission. Rule sets may be defined by a number of rulesthat are based on a number of parameters.

FIG. 3 shows an example interface 300 listing of rule sets stored indata cloud server 105, according to one embodiment. The exampleinterface 300 may provide a listing, via table entry 302, of the rulesets RS1-RS6 stored in data cloud server 105. The rule sets RS1-RS6 maybe used by data cloud server 105 to produce submission reports that aresent to one or more of the secure compute environments 125. Typicallythe submission reports are produced when the information of a case maybe applied to one or more of the rule sets. This may lead to thegeneration of one or more submission reports. Also, each of the securecompute environments 125 may have different criteria for receivingsubmission reports. Also, the format of the submission reports may bedifferent depending the on the information received.

The create button 306 may be provided to allow for the creation of newrules. In some implementations, a user coupled to network 110 may sendto data cloud server 105 new rules. The table listing 302 may include anAPI Name field 308 that lists in a column API Names API_R1-API_R5. Eachrule set RS1-RS5 may correspond to an API Name API_R1-API_R5. The APINames API_R1-API_R5 may be used by data cloud server 105 to access aspecific rule set RS1-RS5 in its memory during processing.

The example interface 300 may include a view button 304 providingfollowing viewing options 304 a-304 c for viewing rule sets RS1-RS5: AllSafety Rule Sets 304 a; Recent Safety Rule Sets 304 b; and Favorite 304c. The viewing option 304 a may allow viewing of all the rule setsRS1-RS5 stored by data cloud server 105. The view option 304 b may allowviewing of recent rule sets RS1-RS5 used or created by data cloud server105. The view option 304 c may allow viewing of rule sets RS1-RS5identified as favorites by data cloud server 105. Moreover, exampleinterface 300 may include filters 305 for filtering rule sets RS1-RS5for viewing in table listing 302. The filters 305 may provide a numberof properties for filtering rule sets RS1-RS5 for viewing in tablelisting 302.

Also, example interface 300 may include an edit button 310 for editingone or more of the rule sets RS1-RS2. In some implementations, the editbutton may include the functionality for debugging and testing theperformance of a specific rule set RS1-RS5.

FIG. 4 shows an example interface 400 listing all rule parameters usedto define a rule, according to one embodiment. Example interface 400 mayinclude detailed information of a rule as shown by table listing 402.The leftmost region 403 of example interface 400 includes a Detailspanel 404 having fields 404 a-404 c. The region 405 of example interface400 also includes fields 404 a-404 c, but here the user may click adrop-down menu providing more detailed information for each field 404a-404 c. Also, when a user clicks one of the fields 404 a-404 c in theleftmost region 403, the user may be directed to the specific clickedfield 404 a-404 c in region 405 to access the clicked field's detailedinformation.

Fields 404 a-404 c may include the following fields: Rule parameters 404a; System 404 b; and Workflow Timeline 404 c.

The table listing 402 may show the following information for each ofrule R1's rule parameters: Rule Parameter Name RP1-RP6; Rule R1;Parameter P1-P6; Value V1-V6; and Rule Set RS1-RS6. In particular, thetable listing 402 shows rule R1 having a number of parameters P1-P6 withthe following rule parameter names RP1-RP6. When the rule R1 is appliedto a case having one or more of the parameters P1-P6, one or more of thevalues V1-V6 are added to the submission report. Note the rule setRS1-RS5 may share the same rule R1 but different values may be assigneddepending on the rule set RS1-RS6 used and parameters P1-P6 that may befound in a case. Values V1-V6 may define where the submission report iseventually distributed and the format the submission report may bepresented in.

The edit button 410 may allow a user to update information for fields404 a-404 c while button 412 may allow a user to preview submissionswith the updated information.

FIG. 5 shows an example interface 500 illustrating a detailed view ofadverse event reports received by data cloud server 105, according toone embodiment. The example interface 500 may include listing portion502 that shows detailed information of adverse event reports received bydata cloud server 104. Note adverse event reports may be received in anInbox format, where one or more adverse event reports are sent byexternal source 112. In particular, table listing 502 lists in columnsthe following content information fields for each adverse event reportInbox: Name AER1-AER6; Lifecycle state L1-L6; Due Date DD1-DD6; ReceiptDate RD1-RD6; New Info Date NID1-NID6; Report Type RT1-RT6; StudyST1-ST6; Product P1-P6, Event E1-E6; and Seriousness SR1-SR6. Thesefields may be inputted using other means, such as a separate window forinput by the user, or are automatically generated/populated by datacloud server 105. The Lifecycle state L1-L6 may be based on severalpredefined state information, which the data cloud server 105 mayautomatically update when a case's Lifecycle state has changed.

The example interface 500 may provide a view panel 504 and a filterpanel 506. The view panel 504 may include the following additionaloptions: All Inbox field 504 a, Recent Inbox 504 b; and Favorites field504 c. When either of the fields 504 a-504 c is clicked by the user, aselect number of cases are displayed in table listing 502. For example,All Inbox field 504 a may allow the user to view all the adverse eventsas stored in data cloud server 105. While the Recent Inbox field 504 bmay allow a user to view recently viewed Inbox. The Favorites field 504c may allow a user to view their more actively viewed Inboxes in tablelisting 502.

Filter panel 506 may include several fields 506 a-506 h used to filterthe number of cases shown in table listing 502. Filter panel 506 mayinclude the following fields:

Due Date field 506 a

Receipt Date field 506 b

New Info Date field 506 c

Report Type field 506 d

Study field 506 e

Product 506 f

Seriousness field 506 g

Relatedness field 506 h

Note the fields 506 a-506 h may correspond to specific fields in tablelisting 502. Filter panel 506 may allow a user to click one or more ofthe fields 506 a-506 h to define one or more filtering parameters. Afiltering operation is performed using the one or more filteringparameters where a select number of adverse event report may bepresented in table listing 502. Also, the example interface 500 mayinclude the edit button 508 that allows for editing the information ofan adverse event report. In some implementations, a drop down menu maybe provided listing which information in an adverse event report can bechanged.

FIG. 6 shows an example interface 600 illustrating a detailed view of acase, according to one embodiment. The example interface 600 may providethe user more detailed information regarding the case N2 as produced bythe data cloud server 105 using one or more adverse event reports asshown in example interface 500. The example interface 600 may includelisting portion 602 that shows detailed information of case N2. Theexample interface 600 may include a Details panel 604 having fields 604a-604 v. Note the Detail panel 604 may not show all the fields 604 a-604w together, but the user may scroll down to see the other remainingfield 604 w.

The region 605 of listing portion 602 may also include fields 604 a-604v, but here the user may click a drop-down menu providing more detailedinformation for each field. Note for purposes of clarity only fields 604s-604 w are shown, but all fields may be displayed by scrolling up ordown. Also, when a user clicks one of the fields 604 a-604 t of Detailpanel 604, the user may be directed to the specific clicked field 604a-604 t in region 605 to access the clicked field's detailedinformation. The region 605 may not show all the fields 604 a-604 wtogether, but the user may scroll up or down to see the other remainingfield 604 a-604 r.

Fields 604 a-604 w may include the following fields: Device Details 604a; Contact 604 b; Patient 604 c; Products 604 d; Adverse Events 604 e;Diagnoses 604 f; Timeline 604 g; Assessments 604 h; Assessment Results604 i; Expectedness 604 j; Medical History and Concurrent Conditions 604k; Drug History 6041; Test Results 604 m; Linked Cases 604 n; ReferenceNumbers 604 o; Validation Results 604 p; Translation 604 q; Submissionsand Distributions 604 r; Action Items 604 s; Documents 604 t; WorkflowTimelines 604 u; Signatures 604 v; and System 604 w.

The region 607 of listing portion 602 may list in columns the followingcontent information fields for the Submissions and Distributions field604 r: Name TR1, Transmission Type TT1, Lifecycle Status L1, DestinationDest1, File F1, and Due Date DD1. The Name field TR1 may identify thename of a submission/distribution. The Transmission Type field TT1 maydefine the format of the submission. The Lifecycle status field L1 maydefine the current lifecycle stage of the submission. In someimplementations, the data cloud server 105 may update the LifecycleStatus field L1 when there is a change. The Destination field Dest1 maydefine the destination for sending the submission after generation. Thefile field F1 may define the location or name of a file that stores thesubmissions. The due date field DD1 may define the due date for sendingthe submission to its corresponding destination.

The edit button 608 may allow a user to update information shown inlisting portion 602 while button 610 may allow a user to preview varioussubmission reports or update information needed for generating asubmission.

FIG. 7 shows an example interface 700 for editing and reviewinginformation of a submitted case, according to one embodiment. Theexample interface 700 is similar to example interface 600. The keydifference is example interface 700 may allow a user to edit and viewdetailed information of a submission. When a user clicks the button 610a drop down menu 702 is presented that may include the following commandoptions: Manage 704, View 706, and Edit 708. The manage command option1106 may provide a user a number of manage sub-options 704 a-704 d andgeneral preview sub-options GP1-GP3 for managing the information andproducing a new version of a submission. The manage sub-option 704 a mayallow to follow up a new version of submission based on additionalinformation. The manage command option 704 may include a number ofpreview sub-options GP1-GP3 for previewing a submission in differentformats. The re-evaluate submissions/distribution sub-option 1106 b mayallow the user to re-evaluate a submission after new information hasbeen provided leading to additional submissions possibly being produced.The recalculate due date sub-option 1106 d may permit the user to changethe due date of a submission for a case.

The view command option 706 may provide a user a number of editingsub-options 706 a-706 c for editing the submitted case. The viewsub-option 706 a may allow the user to view all documents related to thesubmitted case. The view sub-option 706 b may provide the user with anaudit trail of the submitted case for purposes of tracking andmaintenance. The view sub-option 706 c may allow the user thecapabilities to share the submitted case to third parties. In someimplementation, a separate user interface may be provided for the userto enter sharing information.

The edit command option 708 may provide a user a number of editingsub-options 708 a-708 c for editing the submitted case. The editsub-option 708 a may allow the user to make a copy of the caseinformation, as shown in FIG. 7, and add it to a new case or store itfor later use. The edit sub-option 708 b may allow the user to configurethe page layout example interface 700 to their preference. The editsub-option 708 c may allow the user to delete the current submitted casefrom the data cloud server 105.

FIG. 8 shows an example interface 800 illustrating what occurs whensubmission information has been re-evaluated, according to oneembodiment. The table listing 802 of example interface 800 is similar totable listing 602 of example interface 700. The difference between tablelisting 802 and table listing 602 is the table listing 802 include moresubmissions TR1-TR8 then table listing 602 that only has one submissionTR1. This occurs because additional information has been updated in datacloud server 105 for Case N2. Afterwards, either the user or data cloudserver 105 may activate the Re-evaluate Submissions/Distribution field704 c, as described in FIG. 7, to re-evaluate the additional informationof Case N2 by applying the rules of rule sets RS1-RS5 of exampleinterface 300. In this case, additional submissions with Names TR2-TR8were produced as a result of the additional information. Moreover, theadditional submissions TR2-TR8 include the following fields in tablelisting 802: Transmission Type TT2-TT8 Lifecycle Status L2-L8,Destination Dest2-Dest8, File F2-F8, and Due Date DD2-DD8.

FIG. 9 shows a table listing 900 illustrating several rules 902 of arule set RS1, according to one embodiment. The rules set RS1 may includeseveral specific rules 902 a-9021 as indicated by rules header 902 fordevising submissions. In particular, table listing 900 may list incolumns the following content information fields for each of the rules902 a-9021: Name field 906; Order field 908; Regulation 910; LocalExpedited 912; Due in Days 914; and Downgraded 916.

The Name field 906 may indicate the names of each of the rules 902a-9021. In this case, each of the rules 902 a-9021 has a specific namerelated to a specific submission. The order field 908 may indicate avalue for the importance of each rule relative to the others. The lowerthe value of the order field the higher the importance that thesubmission occur timely. In some implementations, the higher the valueof the order field 908 the higher the importance that the submissionoccur timely. The Regulation field 910 may list one or more regulationsfor which each rule was based on for preparing a submission. In thiscase, each rule 902 a-9021 may have a Regulation field 910 that includesregulations Reg1 or Reg2. The regulations Reg1 and Reg2 may be a legalrequirement or contractual requirement defining the specific details ofthe submission. This may include the format for submission, due daterequirements, destination, whether a submission is locally expedited, orthe like.

The Local Expedited field 912, Due in Days field 914, and Downgradedfield 916 may be defined under a Submission (Output) header 904. TheSubmission (Output) header 904 may define for each rule 902 a-9021information the submission must include prior to transmission. Forexample, the rule 902 a may require a submission for public health riskto indicate it is being locally expedited having a due date of 5 daysfor transmission, and the submission does not indicate downgrade in thestatus. In this case, the submission may include a local expedited fieldindicating a yes, a Due in Days field of 5 days, and a Downgrade field916 of No. Once a submission is properly created, the data cloud server105 or user may view or assess the local expedited field, due in daysfield, and downgraded field of the submission to properly prepare thesubmission in a timely fashion for transmission.

The Local Expedited field 912 may include a yes or no value indicatingwhether local expedited transmission processes are initiated or not.When the Local Expedited field 912 is marked yes, the data cloud server105 may assess whether the submission is correctly indicating it isbeing locally expedited in accordance with regulations, and transmit thesubmission on or before the date specified in Due in Days field 914.

The Downgraded field 912 may be associated with the situation where asubmission was previously transmitted for an event of highersignificance but later was deemed to have a lower significance. Therules 902 c-902 f may be associated with rules for downgrading asubmission. For example, the rule 902 c may downgrade a seriousunexpected event to a serious expected event. When the Downgrade field912 is marked yes, the data cloud server 105 may assess whether thesubmission is properly indicating it is downgrading a previously sentsubmission in accordance with regulations, and transmit the submissionon or before the date specified in Due in Days field 914 by data cloudserver 105. Depending on the regulation, data cloud server 105 mayinitiate different transmission processes for downgrading a submission.For example, the data cloud server may need to send two separatesubmissions for downgrading a submission instead of one.

FIG. 10 shows the applicability of the rules in premarket 1002 andpostmarket 1004 studies, according to one embodiment. Premarket events1002 may include clinical trials 1006 and individual patient use studies1008. The premarket clinical trials 1006 may include interventionalclinical trials having a number of phases Phase1-Phase3. The individualpatient use studies 1008 may involve patients having life threateningconditions making them ineligible for clinical trials. Examples ofindividual patient use studies 1008 may include the following:Compassionate Use programs; Name Patient Program; Individual Emergency;Individual Treatment; and Expanded Access.

Postmarket events may include spontaneous reports 1110, other studies1012, a first clinical trial 1014, and second clinical trials 1016. Thespontaneous reports 1010 may be unsolicited adverse event reportstypically received by data cloud server 105. Note spontaneous reports1010 may be assigned a Report Type (RT) of “Spontaneous” in the receivedadverse event report. The other studies 1012 may include observationalstudies from patient support programs or market research programs. Also,the other studies 1012 may be assigned a Study Type (ST) of “Otherstudies.” The first postmarket clinical trial 1014 may include a phase 4postmarket clinical trial. The second postmarket clinical trials 1016may include a Phase1-Phase3 postmarket interventional clinical trials.Note the first postmarket clinical trial 1014 and the second postmarketclinical trials 1016 may each be assigned a Study Type (ST) of “ClinicalTrial” and a Report Type (RT) of “Study.”

When receiving an adverse event report, data cloud server 105 maydetermine whether the adverse event report is associated with apremarket 1002 or postmarket 1004 event based on information from theadverse event report or case information. Once it is determined theadverse event report is associated with premarket event 1002 orpostmarket 1004 event, data cloud server 05 may indicate thisdetermination in the submission if it is required.

Rule sets RS1 and RS2 are provided to show when certain rules may apply.In this case, Suspected Unexpected Serious Adverse Reaction (SUSAR),Serious, Serious Unexpected (SU), and Non-serious submission rules areanalyzed with reference to premarket event 1002 and postmarket event1004.

The rule set RS1 may include a SUSAR submission rule 1018 that is onlyapplicable during premarket clinical trials 1006 and individual patientuse studies 1008. The SU submission rule 1020 for rule set RS1 is onlyapplicable for postmarket spontaneous reports 1010. The rule set RS1 mayinclude a SUSAR submission rule 1022 that is only applicable duringother studies 1012 and the first postmarket clinical trial 1014. Inaddition, the rule set RS1 may include a SUSAR submission rule 1024 thatis applicable during the second postmarket clinical trial 1016.

The rule set RS2 may include a SUSAR submission rule 1026 that is onlyapplicable during premarket clinical trials 1006. Also, the rule set RS2may include a serious and non-serious submission rules 1028 that isapplicable to individual patient use studies, postmarket spontaneousreports, and other studies. The submission rules 1028 may cover bothpremarket and postmarket events. The rule set RS2 may include a SUSARsubmission rule 1030 that is applicable during the first postmarketclinical trial 1014 and the second postmarket clinical trials 1016.

FIG. 11 shows a table listing 1100 illustrating the rules 1102 a-1102 hof the rule set RS2 of FIG. 10, according to one embodiment. The SUSARsubmission rule 1026 of rule set RS2 of FIG. 10 is similar to rule 1102f, and the SUSAR submission rule 1030 is similar to rule 1102 g. Thetable listing 1100 may include Rules header 1102 and Rule parametersheader 1104. The Rules header 1102 may be similar to Rules header 902including the same fields 906-910. The Rule parameters header 1104 mayinclude the following column fields: Report Type 1106; Study Type 1108;Serious 1110; Fatal 1112; and Life Threatening 1114. Each rule 1102a-1102 h may include fields 1104-1114.

Also, each field 1104-1114 may define specific input parameters a caseor adverse event report may include for a submission rule to apply. Inthis case, rule 1102 f may be a SUSAR submission rule at least requiringthe report type field (RT) in an adverse report to be “Study” and thecorresponding study type field (ST) to be “Clinical Trial.” The same mayapply for rule 1102 g. The key difference between rule 1102 f and rule1102 g is the Life Threatening field 1114 of rule 1102 f includes a“Yes” value. The Life Threatening field 1114 of rule 1102 g includes a“Null” value equating to a No value. This may indicate rule 1102 f mayapply to premarket clinical trials 1006 while rule 1102 g may apply tofirst postmarket clinical trial 1014 or second postmarket clinicaltrials 1016.

Rules 1102 d and 1102 h may be similar to the serious and non-serioussubmission rules 1028. Both rules may at least require the report typefield (RT) in an adverse report to be of “Spontaneous” and thecorresponding study type field (ST) to be “Other Studies” or “IndividualPatient Use.” As shown in FIG. 10, this may indicate rules 1102 d or1102 h may be applicable in premarket individual patient use studies1008 or postmarket spontaneous reports or other studies 1012.

Once a submission has been created using rules 1102 a-1102 h, thesubmission may include the information in fields 1106-1114 includingwhether the submission may involve a premarket event or postmarketevent.

FIG. 12 shows an example interface 1200 illustrating a detailed view oftransmission profiles used by data cloud server 105 to preparesubmissions, according to one embodiment. The example interface 1200 mayinclude listing portion 1202 that shows detailed information oftransmission profile by data cloud server 104. Note transmissionprofiles may be used by the data cloud server 104 to prepare and formatsubmissions to be sent to one or more secure compute environments 125.In particular, table listing 1202 may list in columns the followingcontent information fields for each transmission profile: TransmissionProfile Name TPRO1-TPRO10; Origin OR1-OR10; Origin ID ORID1-ORID10;Destination Dest1-Dest5; Destination ID DestID1-DestID10; Report TypeRT1-RT6; Study ST1-ST6; Product P1-P6, Event E1-E6; and SeriousnessSR1-SR6. Also, table listing 102 may also list in a column a backreporting field 1208 for each transmission profile. The back reportingfield 1208 may indicate whether one or more adverse reports or casesthat originated from one or more of the Destinations Dest1-Dest5 requirea submission to be sent to these one or more corresponding DestinationsDest1-Dest5. Certain Destinations Dest1-Dest5 may require a backreported submission and others do not. If a Destination Dest1-Dest5 doesrequire a back reported submission, its corresponding back reportingfield 1208 may be acknowledged by clicking its corresponding check box.Note all of the content information fields for the transmission profiledescribed herein may be inputted using other means, such as a separatewindow for input by the user, or are automatically generated/populatedby data cloud server 105.

The example interface 1200 may provide a view panel 1204 and a filterpanel 1206. The view panel 1204 may include the following additionaloptions: All Transmission Profiles 1204 a, Recent Transmission Profiles1204 b; and Favorites field 1204 c. When either of the fields 1204a-1204 c is clicked by the user, a select number of transmissionprofiles are displayed in table listing 502. For example, AllTransmission Profiles 1204 a may allow the user to view all thetransmission profiles as stored in data cloud server 105. While theRecent Transmission Profiles 1204 b may allow a user to view recentlyviewed transmission profiles. The Favorites field 1204 c may allow auser to view their more actively viewed transmission profiles in tablelisting 1202.

Filter panel 1206 may include several fields 1206 a-1206 b used tofilter the number of transmission profile shown in table listing 1202.Filter panel 1206 may include the following fields: Origin field 1206 aand Destination field 1206 b.

Note the fields 1206 a-1206 b may correspond to specific fields in tablelisting 502. Filter panel 1206 may allow a user to click one or more ofthe fields 1206 a-1206 b to define one or more filtering parameters. Afiltering operation is performed using the one or more filteringparameters where a select number of transmission profiles may bepresented in table listing 1202. Also, the example interface 1200 mayinclude the edit button 1210 that allows for editing the information ofan adverse event report. In some implementations, a drop down menu maybe provided listing which information in an adverse event report can bechanged.

FIG. 13 shows an example interface 1300 illustrating a detailed view ofproduct information used for submission, according to one embodiment.The example interface 1300 may provide the user more detailedinformation regarding the case N3 as produced by the data cloud server105 using one or more adverse event reports as shown in exampleinterface 500. The example interface 1300 may include listing portion1302 that shows detailed information of case N3. The example interface1300 may include a Details panel 1304 having fields 1304 a-1304 t. Notethe Detail panel 1304 may not show all the fields together, but the usermay scroll down to see the other remaining field as needed.

The region 1305 of listing portion 1302 may also include fields 1304a-1304 t, but here the user may click a drop-down menu providing moredetailed information for each field. Note for purposes of clarity onlyfields 1304 d-13041 are shown, but all fields may be displayed byscrolling up or down. Also, when a user clicks one of the fields 1304a-1304 t of Detail panel 1304, the user may be directed to the specificclicked field 1304 a-1304 t in region 1305 to access the clicked field'sdetailed information. The region 1305 may not show all the fields 1304a-1304 t together, but the user may scroll up or down to see the otherremaining fields.

Fields 1304 a-1304 t may include the following fields: Contact 1304 a;Patient 1304 b; Products 1304 c; Adverse Events 1304 d; Assessments 1304e; Assessment Results 1304 f; Causes of Death 1304 g; Medical Historyand Concurrent Conditions 1304 h; Drug History 1304 i; Test Results 1304j; Narrative 1304 k; Linked Cases 13041; Reference Numbers 1304 m;Validation Results 1304 n; Submissions and Distributions 1304 o; ActionItems 1304 p; Documents 1304 q; Workflow Timelines 1304 r; Signatures1304 s; and System 1304 t.

The region 1307 of listing portion 1302 may list in columns thefollowing content information fields for the Products field 1304 c: DrugName DR1-DR3, Rank Rnk1-Rnk3, Product Type PT1-PT3, Drug Role DRR1-DRR3,Product PR1-PR3, Product (Reported) PR1-PR3, and Product (Coded)PR1-PR3. The Drug Name fields DR1-DR3 may identify the names of thedrugs used in a product. The Product Type fields PT1-PT3 may define theproduct type. The Drug Role fields DRR1-DRR3 may define the role of eachdrug used in a product. The Product fields, Product (Reported) fields,and Product (Coded) fields may all be associated with the productsPR1-PR3 for purposes of discussion.

When a user clicks on say Drugs DR1-DR3, a different example interfacemay be presented illustrating details of Drug DR2, which will bedescribe hereinafter.

FIG. 14 shows an example interface 1400 illustrating a detailed view ofdrug information used to prepare submissions, according to oneembodiment. The example interface 1400 may provide the user moredetailed information regarding drug DR2 after clicking the drug DR2 inexample interface 1300. The example interface 1400 may include listingportion 1402 that shows detailed information of Drug DR2. The exampleinterface 1400 may include a Details panel 1404 having fields 1404a-1404 f. Note the Detail panel 1404 may not show all the fieldstogether, but the user may scroll down to see the other remaining fieldas needed.

The region 1405 of listing portion 1402 may also include fields 1404a-1404 f, but here the user may click a drop-down menu providing moredetailed information for each field. Note for purposes of clarity onlyfields 1404 b-1404 d are shown, but all fields may be displayed byscrolling up or down. Also, when a user clicks one of the fields 1404a-1404 f of Detail panel 1404, the user may be directed to the specificclicked field 1404 a-1404 f in region 1405 to access the clicked field'sdetailed information. The region 1405 may not show all the fields 1404a-1404 f together, but the user may scroll up or down to see the otherremaining fields.

Fields 1404 a-1404 d may include the following fields for Drug DR2:Registrations 1404 a; Combination Products 1404 b; Substances 1404 c;Documents 1404 d; Workflow Timeline 1404 e; and System Information 1404f.

The region 1407 of listing portion 1402 may list in columns thefollowing content information fields for the Registration field 1404 a:Registration Name DREG1-DREG3, Country C1-C3, Agency Dest1-Dest3,Registration Type RGT1-RGT2, and Registration Number RGN1-RGN3. TheRegistration Name fields DREG1-DREG3 may identify the variousregistration names of Drug DR2. The Country fields C1-C3 may define thecountry associated with the registration names. The Agency fieldsDest1-Dest3 may define a destination associated with the external source112 for sending an adverse report for a drug having the followingregistration names DREG1-DREG3. The Registration Type fields RGT1-RGT2and Registration Number fields RGN1-RGN3 may correspond to theregistration types and registration numbers associated with registrationnames DREG1-DREG3 for drug DR2.

FIG. 15 shows an example interface 1500 illustrating the case where backreporting is not performed, according to one embodiment. The exampleinterface 1500 is similar to example interface 1300. The differencebetween example interface 1500 and example interface 1300 is the exampleinterface 1500 includes details of Submission and Distribution field1304 o. A listing portion 1502 may show the details of Submission andDistribution field 1304 o.

Region 1507 of listing portion 1502 may list in columns the followingcontent information fields for the Submission and Distribution field1304 o: Transmission Name TR1-TR3, Transmission Type TT1-TT3,Transmission Date TTD1-TTD3, Reason RSS1-RSS3, Origin Dest2 and Dest4,and Destination Dest3 and Dest1. The Transmission Name fields TR1-TR3may be associated with the names of transmissions received or producedby the system. The Transmission Type fields TT1-TT3 may identify whethera transmission is an inbound transmission sent from an external source112 associated with an adverse report or the like or a submission to besent to secure compute environment 125. In this case, the transmissionreport TR1 may include may be an inbound transmission. The TransmissionDate fields TTD1-TTD2 may indicate the date transmission reports TR1-TR3were generated. The Reason fields RSS1-RSS3 may indicate the reasons forgenerating transmission reports TR1-TR3.

The Origin fields Dest2 and Dest3 may also indicate a destination wherethe information underlying the transmission report originated from. Notethe Origin fields may include destinations associated with theDestinations fields Dest1-Dest5 of example interface 1200. In this case,transmission report TR1 originated from Destination Dest2. TheDestination fields Dest3 and Dest1 may indicate the destination where aparticular submission is to be sent. In this case, transmission reportsTR2 and TR3 are the only submissions generated having Destinations Dest3and Dest4, respectively. The transmission report TR1 does not have acorresponding Destination field indicated because it is not a submissionfor the reasons stated above. The Status field may show whethertransmission reports TR1-TR3 are active or inactive.

Based on the Origin field of transmission report TR1, data cloud server105 may determine whether a back report is generated and sent toexternal source 112 that originated the adverse event report producingcase N3. In this case, the location of the external source 112 is Dest2.Typically back reporting is not necessary, however, under certaincircumstances, it is. The example interface 1200 includes the backreporting field 1208 for each transmission profile TPRO1-TPRO10indicating whether a corresponding external source 112 having locationsDest1-Dest5 requires generating a back report. In this case, the exampleinterface 1200 shows neither of the transmission profiles having aDestination field Dest2, associated with the location of an externalsource 112, requires back reporting, as indicated by the correspondingback reporting fields 1208 not being checked or marked.

The edit button 1508 may allow a user to update information shown inlisting portion 1502 while button 1510 may allow a user to previewvarious transmission reports or update information needed for generatinga transmission report.

FIG. 16 shows an example interface 1600 illustrating the case where backreporting is performed, according to one embodiment. The exampleinterface 1600 is similar to example interface 1500. The difference islisting portion 1602 of example interface 1600 shows transmission reportTR1 having its corresponding Origin field changed from Dest2 to Dest3.Due to this change, the data cloud sever 105 generated a back reportTR4, which is a submission report to be sent to an external source 112at location Dest3. The exact location where the adverse even reportproducing case N3 originated. In this case, example interface 1200 showsa transmission profile TPRO9 having a Destination field Dest3,associated with the location of an external source 112, requires backreporting, as indicated by the corresponding back reporting fields 1208being checked or marked. The data cloud server 105 may utilize theinformation in the transmission profiles TPRO1-TPRO10 to determinewhether a back report is generated based on the Origin fields shown inexample interfaces 1500 and 1600.

Workflow

FIGS. 17A-17B show flowcharts 1700 illustrating method for submittingdata in a computer network, according to one embodiment. In block 1702,the method includes receiving, using one or more computing deviceprocessors, a first request to process a first data at one or more dataservers. At block 1704, the method includes determining, using the oneor more computing device processors, whether the first data includes aplurality of first set of properties. At block 1706, the method includesgenerating, using the one or more computing device processors and thefirst set of properties, a second data having a plurality of second setof properties. At block 1708, the method includes storing, using the oneor more computing device processors, the second data at the one or moredata servers, wherein the one or more data servers store the seconddata.

At block 1710, the method includes providing, using the one or morecomputing device processors, at least one rule set for submitting seconddata to one or more external sources, wherein each of the at least onerule set comprises one or more rule parameters for submitting the seconddata. The method includes analyzing, using the one or more computingdevice processors, the second data to determine which one or more rulesfrom the at least one rule set is applicable for submitting the seconddata to the one or more external sources, as shown at block 1712. Also,the method includes selecting, using the one or more computing deviceprocessors, one or more applicable rules from the at least one rule setbased on the analysis of the second data, as shown at block 1714. Atblock 1716, the method includes storing, using the one or more computingdevice processors, the one or more applicable rules in the one or moredata servers.

At block 1718, the method includes retrieving, using the one or morecomputing device processors, the second data from the one or more dataservers. Moreover, the method includes determining, using the one ormore computing device processors, whether the second data includesupdate information for updating the second data, as shown at block 1720.Also, the method includes, in response to the user entering the updateinformation for the second data, receiving, using the one or morecomputing device processors, the update information, as shown at block1722. At block 1724, the method includes, in response to receiving theupdate information, updating, using the one or more computing deviceprocessors, the second data to include the update information.

At block 1726, the method includes retrieving, using the one or morecomputing device processors, the one or more applicable rules from theone or more data servers. The method includes generating, using the oneor more computing device processors, a plurality of third data byapplying the one or more applicable rules to the second data, whereinthe third data comprises a plurality of third set of properties, asshown at block 1728. Moreover, the method includes formatting, using theone or more computing device processors, the third data in accordancewith the one or more applicable rules, as shown at block 1730.

At block 1732, the method includes initiating, using the one or morecomputing device processors, display of the third data and the third setof properties. The method includes identifying, using the one or morecomputing device processors and the third set of properties, the one ormore external sources to distribute the third data, as shown at block1734. Moreover, the method includes sending, using the one or morecomputing device processors, the third data to the one or more externalsources, as shown at block 1736.

In some implementations, when determining whether the first dataincludes the first set of properties, the one or more data cloud servermay parse the first data to assess if the first data includes the firstset of properties. In some implementations, the one or more data serversmay receive an indication from the user of one or more locations of theone or more data servers for retrieving the first data.

In some implementations, when generating the second data, the one ormore data servers may format the first data to be in accordance with aformat used by the second data. In some implementations, when providingthe at least one rule set, the one or more data servers may retrieve theat least one rule set from the one or more data servers. In someimplementations, when analyzing the second data, the one or more dataservers may parse the second data to analyze the second set ofproperties.

In some implementations, when selecting the one or more applicablerules, the one or more data servers may determine which of the secondset of properties apply to the one or more applicable rules based on theanalysis of the second set of properties. In some implementations, whengenerating the third data, the one or more data servers may assign oneor more values to at least one of the third set of properties using theone or more applicable rules. In some implementations, when generatingthe third data, the one or more data servers may produce one or morereports for transmission based on applying the one or more applicablerules to the second data. In some implementations, when identifying theone or more external sources, the one or more data servers maydetermine, using the at least one of the third set of parameters,whether the third data is sent to the one or more external sourceexpeditiously.

In some implementations, when identifying the one or more externalsources, the one or more data servers may determine, using the at leastone of the third set of parameters, whether the third data includesdowngrade information of the second data. In some implementations, whenidentifying the one or more external sources, the one or more dataservers may determine, using the at least one of the third set ofparameters, the timeframe for sending the third data. In someimplementations, when sending the third data, the one or more dataservers may determine, using the at least one of the third set ofparameters, a process for sending the third data

In some implementations, a user interface may be provided for allowingthe user to select one or more locations of the one or more data serversfor retrieving the first data. In some implementations, a user interfacemay be provided for displaying details of the first data. In someimplementations, a user interface may be provided for editinginformation of the first data. In some implementations, the userinterface may display and update information regarding the firstinformation. In some implementations, a user interface may be providedfor displaying details of the at least one rule set. In some instance, auser interface may be provided displaying details of the third data.

Reference in the specification to “one implementation” or “animplementation” means that a particular feature, structure, orcharacteristic described in connection with the implementation isincluded in at least one implementation of the disclosure. Theappearances of the phrase “in one implementation,” “in someimplementations,” “in one instance,” “in some instances,” “in one case,”“in some cases,” “in one embodiment,” or “in some embodiments” invarious places in the specification are not necessarily all referring tothe same implementation or embodiment. In some embodiments, the terms“signal,” “data,” and/or “information” may be used interchangeably. Insome embodiments, signals refer to non-transitory signals.

Finally, the above descriptions of the implementations of the presentdisclosure have been presented for the purposes of illustration anddescription. It is not intended to be exhaustive or to limit the presentdisclosure to the precise form disclosed. Many modifications andvariations are possible in light of the above teaching. It is intendedthat the scope of the present disclosure be limited not by this detaileddescription, but rather by the claims of this application. As will beunderstood by those familiar with the art, the present disclosure may beembodied in other specific forms without departing from the spirit oressential characteristics thereof. Accordingly, the present disclosureis intended to be illustrative, but not limiting, of the scope of thepresent disclosure, which is set forth in the following claims.

What is claimed is:
 1. A method for submitting data in a computernetwork, the method comprising: receiving, using one or more computingdevice processors, a first request to process a first data at one ormore data servers; determining, using the one or more computing deviceprocessors, whether the first data includes a plurality of first set ofproperties; generating, using the one or more computing deviceprocessors and the first set of properties, a second data having aplurality of second set of properties; storing, using the one or morecomputing device processors, the second data at the one or more dataservers; providing, using the one or more computing device processors,at least one rule set for submitting second data to one or more externalsources, wherein each of the at least one rule set comprises one or morerule parameters for submitting the second data; analyzing, using the oneor more computing device processors, the second set of properties of thesecond data to determine which one or more rules from the at least onerule set is applicable for submitting the second data to the one or moreexternal sources, wherein the one or more rules include one or moreapplicable rules for managing downgrade information of the second data;selecting, using the one or more computing device processors, the one ormore applicable rules for managing the downgrade information of thesecond data from the at least one rule set based on the analysis of thesecond data; storing, using the one or more computing device processors,the one or more applicable rules for managing the downgrade informationof the second data in the one or more data servers; retrieving, usingthe one or more computing device processors, the second data from theone or more data servers; determining, using the one or more computingdevice processors, whether the second data includes downgradeinformation for updating the second data; in response to the userentering downgrade information for the second data, receiving, using theone or more computing device processors, the downgrade information; inresponse to receiving the downgrade information, updating, using the oneor more computing device processors, the second data to include thedowngrade information; retrieving, using the one or more computingdevice processors, the one or more applicable rules for managing thedowngrade information of the second data from the one or more dataservers; generating, using the one or more computing device processors,a plurality of third data by applying the one or more applicable rulesfor managing the downgrade information of the second data to the seconddata, wherein the third data comprises a plurality of third set ofproperties; formatting, using the one or more computing deviceprocessors, the third data in accordance with the one or more applicablerules for managing the downgrade information of the second data;initiating, using the one or more computing device processors, displayof the third data and the third set of properties; identifying, usingthe one or more computing device processors and the third set ofproperties, the one or more external sources to distribute the thirddata; and sending, using the one or more computing device processors,the third data to the one or more external sources based on at least oneof the third set of properties.
 2. The method of claim 1, whereindetermining whether the first data includes the first set of propertiescomprises parsing the first data to assess if the first data includesthe first set of properties.
 3. The method of claim 2, wherein receivingthe first request to process the first data comprises receiving anindication from the user of one or more locations of the one or moredata servers for retrieving the first data.
 4. The method of claim 1,wherein generating the second data comprises formatting the first datato be in accordance with a format of the second data.
 5. The method ofclaim 1, wherein providing the at least one rule set comprisesretrieving the at least one rule set from the one or more data servers.6. The method of claim 1, wherein analyzing the second data comprisesdetermining whether the downgrade information is associated with alowering in severity of an event identified in an event field in thesecond data.
 7. The method of claim 1, wherein selecting the one or moreapplicable rules for managing the downgrade information of the seconddata comprises determining which of the second set of properties applyto the one or more applicable rules for managing the downgradeinformation of the second data based on the analysis of the second setof properties.
 8. The method of claim 1, wherein generating the thirddata comprises assigning one or more values to at least one of the thirdset of properties using the one or more applicable rules for managingthe downgrade information of the second data.
 9. The method of claim 1,wherein generating the third data comprises producing one or morereports for transmission based on applying the one or more applicablerules for managing the downgrade information of the second data to thesecond data.
 10. The method of claim 1, wherein identifying the one ormore external sources comprises determining, using the at least one ofthe third set of parameters, whether the third data comprises thedowngrade information of the second data that is sent to the one or moreexternal sources.
 11. The method of claim 1, wherein identifying the oneor more external sources comprises determining, using the at least oneof the third set of parameters, whether the third data includes anindication of a level of the downgrade information of the second data.12. The method of claim 1, wherein identifying the one or more externalsources comprises determining, using the at least one of the third setof parameters, a timeframe for sending the third data.
 13. The method ofclaim 1, wherein sending the third data comprises determining, using theat least one of the third set of parameters, a process for sending thethird data
 14. A system for submitting data in a computer network, thesystem comprising one or more computing device processors; and one ormore computing device memories, coupled to the one or more computingdevice processors, the one or more computing device memories storinginstructions executed by the one or more computing device processors,wherein the instructions are configured to: receive a first request toprocess a first data at one or more data servers; determine whether thefirst data includes a plurality of first set of properties; generate,using the first set of properties, a second data having a plurality ofsecond set of properties; store the second data at the one or more dataservers; provide a plurality of rule sets for submitting second data toone or more external sources, wherein each of the rule sets comprisesone or more rule parameters for submitting the second data; analyze thesecond set of properties of the second data to determine which one ormore rules from the at least one rule set is applicable for submittingthe second data to the one or more external sources, wherein the one ormore rules include one or more applicable rules for managing downgradeinformation of the second data; select the one or more applicable rulesfor managing the downgrade information of the second data from the rulesets based on the analysis of the second data; store the one or moreapplicable rules for managing the downgrade information of the seconddata in the one or more data servers; retrieve the second data from theone or more data servers; determine whether the second data includes thedowngrade information for updating the second data; in response to theuser entering the downgrade information for the second data, receive thedowngrade information; in response to receiving the downgradeinformation, update the second data to include the downgradeinformation; retrieve the one or more applicable rules for managing thedowngrade information of the second data from the one or more dataservers; generate a plurality of third data by applying the one or moreapplicable rules for managing the downgrade information of the seconddata to the second data, wherein the third data comprises a plurality ofthird set of properties; format the third data in accordance with theone or more applicable rules for managing the downgrade information ofthe second data; initiate display of the third data and the third set ofproperties; identify, using the third set of properties, the one or moreexternal sources to distribute the third data; and send the third datato the one or more external sources.
 15. The system of claim 11, whereinthe instructions are further configured to provide a user interface forallowing the user to select one or more locations of the one or moredata servers for retrieving the first data.
 16. The system of claim 11,wherein the instructions are further configured to provide a userinterface for displaying details of the first data.
 17. The system ofclaim 11, wherein the instructions are further configured to provide auser interface for editing information of the first data.
 18. The systemof claim 11, wherein the instructions are further configured to providea user interface for displaying details of the at least one rule set.19. The system of claim 11, wherein the instructions are furtherconfigured to provide a user interface for displaying details of thethird data.
 20. A method for submitting data in a computer network, themethod comprising: receiving, using one or more computing deviceprocessors, a first request to process a first data at one or more datacloud servers; determining, using the one or more computing deviceprocessors, whether the first data includes at least one of a first setof properties; generating, using the one or more computing deviceprocessors and the at least one of the first set of properties, a seconddata having at least one of a second set of properties; storing, usingthe one or more computing device processors, the second data at the oneor more data cloud servers; providing, using the one or more computingdevice processors, at least one rule set for submitting second data toone or more external sources, wherein the at least one rule setcomprises at least one rule parameter for submitting the second data;analyzing, using the one or more computing device processors, the secondproperties of the second data to determine at least one rule from the atleast one rule set is applicable for submitting the second data to theone or more external sources, wherein the at least one rule includes atleast one applicable rule for managing downgrade information of thesecond data; selecting, using the one or more computing deviceprocessors, the at least one applicable rule for managing the downgradeinformation of the second data from the at least one rule set formanaging the downgrade information of the second data based on theanalysis of the second data; storing, using the one or more computingdevice processors, the at least one applicable rule for managing thedowngrade information of the second data in the one or more data cloudservers; retrieving, using the one or more computing device processors,the second data from the one or more data cloud servers; determining,using the one or more computing device processors, whether the seconddata includes the downgrade information for updating the second data; inresponse to the user entering information for the second data,receiving, using the one or more computing device processors, thedowngrade information; in response to receiving the downgradeinformation, updating, using the one or more computing deviceprocessors, the second data to include the downgrade information;retrieving, using the one or more computing device processors, the atleast one applicable rule for managing the downgrade information of thesecond data from the one or more data cloud servers; generating, usingthe one or more computing device processors, a plurality of third databy applying the at least one applicable rule for managing the downgradeinformation of the second data to the second data, wherein the thirddata comprises at least one of a third set of properties; formatting,using the one or more computing device processors, the third data inaccordance with the at least one applicable rule for managing thedowngrade information of the second data; initiating, using the one ormore computing device processors, display of the third data and the atleast one of the third set of properties; identifying, using the one ormore computing device processors and the third set of properties, theone or more external sources to distribute the third data; and sending,using the one or more computing device processors, the third data to theone or more external sources.